August 26, 2013
Member Alert: Letter Trifecta
IACP is aware of the three letters currently circulating to our members - the Aptalis Pharma letter regarding RECTIV, the Arnall Golden Gregory letter regarding Mitosol, and the Express Scripts letter stating that compounded drugs using bulk chemicals will no longer be covered.
Click here for a copy of the Aptalis letter.
Click here for a copy of the Arnall Golden Gregory LLP (Mitosol) letter.
Click here for the Express Scripts letter.
IACP will be sending all members an email and fax on how to handle these specific letters. In the meantime, please visit IACP's AdvanCE self-paced webinars on our website. Click here to access IACP's webinar, Sound & Fury: Responding to Manufacturers’ Cease & Desist Letters.
This webinar will answer your questions, “What should I do? Ignore it? Send it to my attorney? Comply with their request? Why did I get this in the first place? Who are these people anyway?” This program will help you understand what a “cease-and-desist” letter is, where it comes from, what it means, and what to do about it. Stay tuned for more information to come.
Another FDA Salvo Against Compounding?
Last week, the Food and Drug Administration issued a national statement advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., located in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating. According to the agency, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results.
Additionally, the FDA recommended that pharmacies not use this firm for sterility and other quality attributes at this time. Since that announcement, the agency has contacted many compounding pharmacies specifically requesting a recall of sterile medications tested by Front Range. Several IACP members have conducted additional in-house testing on their lots -- all showing and confirming that the Front Range results were aligned with their own.
In a statement to its clients, Front Range Laboratories stated: "We are not in the business of manufacturing and do not conduct business with entities that manufacture finished drug products. We are not aware of a single client registered with the FDA as a drug manufacturer. Yet, during this recent inspection, our operations were inspected against the FDA's Current Good Manufacturing Practice (or cGMP) regulations which, by definition, do not legally apply to compounding pharmacies unless they are acting as manufacturers."
Front Range adds that: "For over 10 years of operation, Front Range Laboratories has relied on state law (boards of pharmacy) and United States Pharmacopeia (USP) guidance when performing all of our testing. Specifically, the methods we use to assess sterility and other quality attribute testing are put forth by USP. Patient safety is an ongoing and primary concern within our industry, and Front Range Laboratories has always been extremely diligent in adhering to applicable guidelines as put forth by the organizations that govern the compounding pharmacy community. Our exceptional safety record is proof positive of our actions."
Once again, the FDA is applying a different rulebook to inspections, this time to laboratories that specifically service compounding pharmacies. Rather than inspecting pharmacies to USP standards, as required by many state laws and pharmacy practice acts, the FDA has issued inspection reports citing pharmacies' violations of cGMPs. Now the laboratories are being held accountable to cGMP standards. Front Range is not the first testing lab to have been inspected in the past few months. And shortly, final regulations will be put in place to further enable the agency to halt the importation of APIs including those which are not components of FDA approved drugs.
To date, there has been no evidence whatsoever that a compounded preparation tested by Front Range failed to meet USP standards nor have any medications been deemed sterile that have in actuality found to be non-sterile. IACP members should continue to use the laboratory of their choice and raise any concerns about previous or ongoing inspections of those labs with the operators.
Click here for the FDA alert.
IACP Members: If you have questions or concerns, please contact us at email@example.com, or call 281/933-8400.
WSOCTV Ch 9 Interviews IACP Member Doug Yoch on How S. 959 Could Harm Patients
Thank you to IACP Member Doug Yoch, PharmD, Stanley Apothecary in Charlotte, N.C., for educating his local media, WSOCTV Channel 9, on how S. 959 in its current form could negatively impact his patients, as well as the local economy.
Click here to view the WSOCTV print and broadcast story.
IACP Members: If you need assistance in telling your story to your local media, please contact IACP for help with message points and media training!
IACP Serves on International Committee
IACP’s Director of Membership, Lindsey Turnau, has been selected to serve on the American Society of Association Executive’s International Committee (ASAE). ASAE is the largest organization of staff that work for non-profit associations, like IACP. Because Lindsey is based internationally, this was a perfect match between what IACP has accomplished to date and our long term goal of growing the Academy globally.
Many of the issues that compounders face are the same, regardless of location. IACP hopes to find models and processes that will help our members here in the USA; but, also provide transfer of that knowledge back and forth across the globe. The ultimate goal is to have an enhanced information exchange between compounders internationally.
Lindsey says, “At my first meeting I realized that we are ahead of the curve as we have been committed to international pharmacy for many years. What many organizations are struggling with is how to have a greater global presence, while still keeping to their mission. On this committee, I’ll be able to share our strategy and also learn the most successful tactics already in place.” The two year term comes at a perfect time, as IACP is exploring more international opportunities and securing a more permanent place on the global scale. For more information, or to speak directly with IACP regarding our international outreaches, please contact Lindsey at Lindsey@iacprx.org.
Corporate Partner Spotlight: Freedom Pharmaceuticals
Great things come with Freedom!
Freedom Pharmaceuticals, Inc. specializes in the custom wholesale distribution of premium compounding chemicals – active pharmaceutical ingredients (APIs), excipients and pre-made bases – to independent compounding pharmacies throughout the United States. We are continually expanding our product offering based on our customer’s needs. Our team of experts has over 100 years of combined experience.
At Freedom, our goals are simple: supply your compounding pharmacy with the highest quality fine chemicals available and give your staff the personalized customer service necessary to operate successfully in this rapidly changing industry. Built on the belief that customer service and quality chemicals are paramount, Freedom Pharmaceuticals strives to meet the ever changing demand of independent compounding pharmacies and their patients. Our commitment to quality and exceptional
customer service is evident in all we do. At Freedom, we have our finger on the pulse of compounding and we help our customers remain on the forefront of this rapidly changing industry.
Upon becoming a Freedom customer, you will immediately experience the Freedom 5 Star Advantage:
- Insurance/Third-Party Support, Guidance & Consulting
- A True Custom Supplier
- NO MEMBERSHIP FEES or Contractual Obligations
- Competitive Pricing
- First-Class Customer Service
The Contributor List is Growing! Thank you for Donating to your Profession's Future.
IACP is working to Protect, Promote & Advance Pharmacy Compounding. Please help IACP continue our ongoing legislative, regulatory and press efforts on issues including: S. 959, reimbursement, and preserving patients and practitioners' access to pharmacy compounds. With your help, IACP can continue to play an active role in protecting our profession.
Please click the Donate button above to access an IACP donation form. One-time sums, or monthly contributions are both available for your consideration. We greatly appreciate anything you can do to help support our efforts, and for being an IACP Member!
We Thank the IACP Members and Corporate Partners Contributing to the Academy!
Click here to view the entire list.
New Staff Member Joins IACP
IACP is happy to announce Lauren Palliser as the Events & Education Assistant. Lauren is a recent graduate from the University of Louisiana at Lafayette with a Bachelor of Arts in Communication. During her senior year, Lauren held a Public Relations Internship at the Louisiana IceGators, a professional hockey league. While working for the IceGators, Lauren organized and carried out promotional events, wrote radio spots, worked with local media, and assisted in onsite event logistics. In her new role at IACP, Lauren assists with the coordination of both Compounders on Capitol Hill and the Educational Conference as well as the IACP Corporate Partner program. Please join us in welcoming Lauren to the IACP team!
Educational Conference Social Media Sites Launched!
The ACA, IACP, ACVP Educational Conference is pleased to announce the launch of the Educational Conference 2014 social media sites, including Facebook, Twitter and Instagram. These social media sites are a great way for attendees to stay up-to-date on the latest information regarding meeting activities, view speaker videos, as well as connect and network with fellow colleagues. Stay tuned for exciting new updates including future announcements and contests. Remember to use #EduCon2014 when tagging posts or pictures!
Advance discount deadline ends on or before December 3, 2013. For the latest conference news, visit www.EducationalConference.org.
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida
The Educational Conference Goes to Fort Lauderdale, Florida, February 5-8, 2014
Registration Is Now Open!
Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 5-8, 2014 at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.
What you can expect in 2014:
- Benefit from multiple education tracks; practice-based, compounding, and veterinary clinical and compounding.
- Learn the fundamental steps to successfully work with your local media.
- Develop a Social Media campaign about your pharmacy and its role in the community.
- Leverage the latest tools and resources to implement a quality improvement plan in your pharmacy.
- Hear what your peers are doing in the This Works for Me! sessions.
- Tips for hiring and retaining good employees for a successful pharmacy.
- What’s New in Veterinary Pharmacy, and much more!
- Visit with companies showcasing services that can improve your business.
Click here to read more!
IACP Regional Education Meetings in Salt Lake City, Utah and Tulsa, Okla!
The IACP Regional Education Meeting brings 2.0 contact hours (.20 CEUs) of live pharmacy law continuing education credit to pharmacists and technicians all across the United States. We hope you’ll join us for an evening of legislative and regulatory education, Q&A, and networking with your local compounders! For more information, please visit www.iacprx.org/RegionalEducationMeetings.
Title: Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that affect you and your practice.
Speaker: David G. Miller, RPh, IACP’s Executive Vice President & CEO
CE Credit: 2.0 contact hours (.20 CEUs) of ACPE-approved LIVE LAW continuing education credit; knowledge based
At the conclusion of this seminar, the pharmacist and technician attendee will be able to:
- Explain how compounders are regulated and enforced by the State Boards of Pharmacy, Food and Drug Administration (FDA), and Drug Enforcement Administration (DEA).
- List four different regulatory initiatives and two court cases that have defined FDA’s oversight to compounders.
- State what authority the FDA has when inspecting compounding pharmacies.
- Define “bulk ingredients” and the difference between “FDA-approved” products.
- Define “office use” and describe how compounding for office use differs from wholesaling.
- Describe key components of federal proposed legislation that may change the balance of existing federal and state authorities
Salt Lake City, Utah – September 26, 2013
6:30 - 7:30 p.m. Check-in period with pizza & refreshments
7:30 - 9:30 p.m. Educational Session
9:30 - 10:00 p.m. Q&A with David Miller and Department of Professional Licensing’s Compounding Task Force: Kavish Choudary, Christopher Cox, Kort Delost, Missy Duke, Trip Hoffman, Christine Jacobsen, Dean Jolley, Adam Jones, Wayne Jones, Dallas Moore, Jim Ruble, Evan Vickers, Angela Whitney, and Victoria Zippi
Roseman University of Health Sciences, P2 Classroom, 1st Floor
10920 S. River Front Parkway, South Jordan, UT 84095
Click here to view the event flyer for more details!
Tulsa, Oklahoma – November 9, 2013
5:00 - 7:30 p.m.
Hyatt Regency Tulsa, Diplomat Room, 2nd Floor
100 East 2nd Street, Tulsa, OK 74103
Click Here to View the Event Flyer for More Details!
This meeting will correspond with Freedom’s November CPCSI training and the Freedom Pharmaceuticals 2nd Annual Seminar. More information coming soon.
Would You Like to Sponsor or Host an IACP Regional Education Meeting in Your City?
If you would like IACP to plan a Regional Education Meeting in your city, please email Michelle Atkinson or call 281.933.8400. For more information on sponsorship, please click here. For more information on hosting, please click here.
IACP is your one-stop resource for all things compounding! CompounderCalendar provides a comprehensive listing of compounding events and continuing education programs.
Click here to view IACP’s Upcoming Events.
IACP Career Center
Welcome to the IACP Career Center!
Your destination for exciting job opportunities and the best resource for qualified candidates within the Industry.
Click here to view the IACP Career Center.
Stay connected to IACP by joining our online communities!